Biomedical (Biomed) Refresher 1

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About this Course

This Refresher 1 course highlights important concepts from the Human Subjects Research – Biomedical (Biomed) basic course. It covers historical and current information on regulatory and ethical issues important to the conduct of research involving human subjects. It also explores topics with added depth to retrain learners on key points from the basic course.

It should be completed after learners complete the basic Human Subjects Research – Biomed course. It is generally recommended that organizations select refresher content requirements that reflect their selections for the basic course(s). Refresher courses should be taken in a cycle at an interval specified by your organization (for example, Refresher Stage 1: 3 years after completion of basic course; Refresher Stage 2: 6 years after completion of basic course).

Biomed Refresher 1 – Informed Consent

Reviews key concepts from the basic module Informed Consent. Identifies the process of informed consent, describes the steps necessary to ensure human research subjects are provided the necessary information to make informed choices about their participation in research, and discusses the IRB’s role in reviewing informed consent process and documentation.

Note: It is recommended that this module be Required or Supplemental depending on the learner group.

Biomed Refresher 1 – SBR Methodologies in Biomedical Research

Highlights essential topics from the basic module Social and Behavioral Research (SBR) for Biomedical Researchers, including identifying the risks of harm to subjects associated with SBR and presenting some reasons why SBR may be perceived as low risk.

Note: It is recommended that this module be Required or Supplemental depending on the learner group.

Biomed Refresher 1 – Records-Based Research

Identifies what levels of regulatory authority apply to research with records, describes the steps to ensure the protection of privacy and confidentiality when using existing records for research, and discusses the IRB’s role regarding informed consent (and waiver of consent) to collect data from existing records. Also discusses what makes records-based research exempt from federal regulations 45 CFR 46, as previously covered in basic module Records-Based Research.

Biomed Refresher 1 – Genetics Research

Describes the difference between genetic privacy and confidentiality, lists the information that should be disclosed to subjects during the consent process associated with genetics research, and describes some of the risks of harm associated with genetic research. Expands on concepts covered in the basic module Genetic Research in Human Populations.

Discusses the types of vulnerability that may exist in research subjects and identifies aspects of study design that may make research subjects vulnerable. Summarizes key points from basic module Populations in Research Requiring Additional Considerations and/or Protections.

Biomed Refresher 1 – Research Involving Prisoners

Describes why prisoners need special protections as subjects, identifies the types of research permitted with prisoners, and explains what to do if a subject becomes a prisoner during a research study. Highlights topics covered in basic module Vulnerable Subjects – Prisoners.

Note: It is recommended that this module be Required or Supplemental depending on the learner group.

Provides refresher training for the basic module Vulnerable Subjects – Pregnant Women, Human Fetuses, and Neonates. Reviews when research involving pregnant women or fetuses is permitted, who may be involved in the decision to terminate a pregnancy, and when consent of the mother or the father is required in keeping with 45 CFR 46, Subpart B.

Note: It is recommended that this module be Required or Supplemental depending on the learner group.

Biomed Refresher 1 – FDA-Regulated Research

Explains the role of the FDA and when an investigational new drug (IND) application may be necessary. Defines what constitutes "off label" use of drugs, devices, and biologics and covers emergency use of an investigational biologic, drug, or device in human subject research. Provides in-depth review of topics covered in module FDA-Regulated Research.

Note: It is recommended that this module be Required or Supplemental depending on the learner group.

Biomed Refresher 1 – Research and HIPAA Privacy Protections

Discusses the HIPAA requirements for research data related to security and explains data security goals of researchers and organizations in light of HIPAA and similar requirements. Summarizes key issues identified in basic module Research and HIPAA Privacy Protections.

Note: It is recommended that this module be Required or Supplemental depending on the learner group.